Stanbio Laboratory, LP: Medical Device Recall in 2021 - (Recall #: Z-2199-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.

Product Classification:

Class III

Date Initiated: July 12, 2021

Date Posted: August 11, 2021

Recall Number: Z-2199-2021

Event ID: 88323

Reason for Recall:

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Status: Terminated

Product Quantity: 7,108 products

Code Information:

Catalog Number/Product Description: 2440-058/¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000519 Lot Numbers: 164312; 161081; 161039; 161031; 158972;

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

Voluntary or Mandated:

Voluntary: Firm initiated